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Symptoms of Acute Bronchitis Accompanied by Coughing | Prospan® Hustenzäpfchen - Investigation on Efficacy and Tolerability in Children

Symptoms of Acute Bronchitis Accompanied by Coughing research study

What is the primary objective of this study?

The aims of this study are - Demonstrating superior efficacy of Prospan® Hustenzäpfchen compared to Placebo in children suffering from acute bronchitis accompanied by coughing - Characterisation of safety and tolerability of Prospan® Hustenzäpfchen in comparison with placebo.

Who is eligible to participate?

Inclusion Criteria: 1. male or female children aged 0 to 6 years 2. acute bronchitis existing not longer than three days and accompanied by coughing 3. symptom rating score of ≥ 5 assessed by the investigator 4. symptom 'frequency of coughing' of ≥ 2 assessed by the investigator 5. the patient's legal representatives must give informed consent in accordance with the supposed will of the patient, after having been informed about benefits and potential risks of the trial, as well as details of the insurance taken out to cover the risk for patients participating in the study - Exclusion Criteria: 1. hypersensitivity to the active ingredient or to any further constituents of the pharmaceutical preparations 2. patients with severe allergies or multiple drug allergies 3. any other pulmonary disease within the last two weeks 4. chronic pulmonary diseases 5. exacerbation of chronic pulmonary disease 6. suspicion of bacterial pulmonary infection 7. fever above 39°C (rectal measurement) -

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Symptoms of Acute Bronchitis Accompanied by Coughing

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Suppositories containing Ivy leaves dry extractSuppositories containing Ivy leaves dry extract

Drug:PlaceboSuppositories containing no Ivy leaves dry extract

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Prospan Hustenzäpfchen

Placebo

Study Status

Unknown status

Start Date: October 2008

Completed Date: August 2013

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Primary outcome measure

Secondary Outcome: Secondary variables

Study sponsors, principal investigator, and references

Principal Investigator: Gerhard Zwacka, Prof. Dr.

Lead Sponsor:

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01127048

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